Personal diagnostic devices including related methods and systems

Abstract

A personal diagnostic patch device for biological analysis includes a sample acquisition layer for obtaining a fluid sample, a fluidic processing layer including a fluidic circuit for directing fluid flow, an assay results detection layer having a detector for detecting diagnostic results derived from fluid sample analysis, and a processor and transmitter for sending diagnostic results to a remote location. The layers are situated in register with each other and operatively attached with constituent elements in alignment to form the fluidic circuit for sample processing, detection, and analysis. Related systems include a remotely located user computer for receiving a signal from the patch device when the device is provided with the transmitter. The user computer may be connected to a network including any one or more of several different medical providers. Methods include use of the patch device for specific applications, related processes, and steps for manufacturing and assembling.

What we claim is: 
     
       1. A personal diagnostic device for analysis of a fluid sample, comprising:
 a sample acquisition layer for obtaining a fluid sample from a user, said sample acquisition layer being associated with a light source; 
 a fluidic processing layer in fluid communication with said sample acquisition layer and configured to process said fluid sample, said fluidic processing layer including a fluidic circuit configured to direct said fluid sample to an analysis chamber, said fluidic circuit containing different chambers for sample processing, detection, and analysis; 
 an assay results detection layer having a detector for detecting diagnostic results derived from said processing of said fluid sample; 
 a signal processing layer, a controller layer, and an input/output layer including a display configured to display at least some of said diagnostic results of said fluid sample after analysis, and said sample acquisition layer, said fluidic processing layer, and said assay results detection layer are in register with each other and are operatively attached to each other to form said fluidic circuit, and said light source, analysis chamber, and detector are in register with each other such that light emitted from said light source passes through said analysis chamber and is detectable by said detector. 
 
     
     
       2. The device according to  claim 1  further comprising at least one chamber containing a pressurized gas. 
     
     
       3. The device according to  claim 1  further comprising at least one chamber containing a vacuum. 
     
     
       4. The device according to  claim 1  further comprising hydrophobic surfaces for retarding fluid flow. 
     
     
       5. The device according to  claim 1  further comprising hydrophilic surfaces for promoting fluid flow. 
     
     
       6. The device according to  claim 1  further comprising a sound emitter for providing said user with feedback. 
     
     
       7. The device according to  claim 1  further comprising a logic processing system. 
     
     
       8. The device according to  claim 7  further comprising an Internet Protocol address within said logic processing. 
     
     
       9. The device according to  claim 1  further comprising an air sample acquisition member for obtaining and testing an air sample from the ambient environment of a user. 
     
     
       10. The device according to  claim 7  wherein said logic processing system has TCP/IP. 
     
     
       11. The device according to  claim 1  further comprising a receiver and a transmitter to provide telemetry information regarding location of said user. 
     
     
       12. The device according to  claim 7  wherein said logic processing system generates output information regarding a medical state of the user. 
     
     
       13. The device according to  claim 12  further comprising a memory for storing said output information. 
     
     
       14. The device according to  claim 1  further comprising a receiver, and a controller associated said controller layer wherein a return command from a first remote location is received by said receiver, and processed by said processor and said controller to thereby activate a desired functionality within the device. 
     
     
       15. The device according to  claim 1  further configured to perform a cellular assay. 
     
     
       16. The device according to  claim 1  further configured to perform a small molecule assay. 
     
     
       17. The device according to  claim 1  further configured to perform a glucose assay. 
     
     
       18. The device according to  claim 1  further configured to perform a stress assay. 
     
     
       19. The device according to  claim 1  further configured to perform a cortisol assay. 
     
     
       20. The device according to  claim 1  further configured to perform an enzyme assay. 
     
     
       21. The device according to  claim 1  further configured to perform a lactate assay. 
     
     
       22. The device according to  claim 1  further configured to perform a cardiac marker assay. 
     
     
       23. The device according to  claim 1  further configured to perform a creatinine assay. 
     
     
       24. The device according to  claim 1  further configured to perform a hemoglobin assay to detect anemia. 
     
     
       25. The device according to  claim 1  further comprising tubules, lancets, or microprobes configured to draw up blood or fluid samples for testing. 
     
     
       26. The device according to  claim 25  further comprising an anticoagulant in said tubules, lancets, or microprobes. 
     
     
       27. The device according to  claim 25  further comprising programmable valves to flush out any old blood accumulated at tips of said tubules, lancets, or microprobes. 
     
     
       28. The device according to  claim 1  further comprising a transmitter operatively associated with a processor and a memory, said transmitter enabled to wirelessly transmit an electronic signal including at least some information about said diagnostic results from said personal diagnostic device to a remote location. 
     
     
       29. The device according to  claim 28  further configured to interface with a computer device remotely maintained from said personal diagnostic device, said computer device including a receiver for receiving said electronic signal so that said at least some of said information about said diagnostic results is thereby transferred from said personal diagnostic device to said computer device for further processing. 
     
     
       30. The device according to  claim 28  further comprising a logic processing system operatively associated with said processor and implemented within said personal diagnostic device to control operational functions of said personal diagnostic device. 
     
     
       31. The device according to  claim 30  further comprising an address within said logic processing system so that said device is addressable remotely over a network. 
     
     
       32. The device according to  claim 28  wherein said detector includes a charged coupled device (CCD) for detecting electro-magnetic energy after interaction thereof with said diagnostic results. 
     
     
       33. The device according to  claim 28  wherein said detector includes at least one light receiving nano-wire for detecting electro-magnetic energy after interaction thereof with said diagnostic results. 
     
     
       34. The device according to  claim 28  wherein said detector includes at least one light receiving micro-wire for detecting said electro-magnetic energy after interaction thereof with said diagnostic results. 
     
     
       35. The device according to  claim 28  wherein said detector includes a semi-conductor light detecting material for detecting said electro-magnetic energy after interaction thereof with said diagnostic results. 
     
     
       36. The device according to  claim 29  wherein said computer device includes a monitor and said at least some of said information about said diagnostic results is displayed on said monitor. 
     
     
       37. The device according to  claim 28  wherein said computer device is a desk top computer. 
     
     
       38. The device according to  claim 29  wherein said computer device is a lap top computer. 
     
     
       39. The device according to  claim 29  wherein said computer device is a hand-held computer. 
     
     
       40. The device according to  claim 29  further comprising a receiver operatively associated with said processor for accepting a control command signal from said computer device. 
     
     
       41. The device according to  claim 29  wherein said computer device is linked to a network and said network is further linked to a medical provider's computer system so that said information about said diagnostic results is accessible by a medical provider at a remote location. 
     
     
       42. The device according to  claim 40  wherein said computer device is linked to a network and said network is further linked to a medical provider's computer system so that a medical provider at a remote location is thereby enabled to send said control command to said personal diagnostic device. 
     
     
       43. The device according to  claim 28  further comprising a plurality of remote receivers implemented within a respective physical environment to wirelessly receive said electronic signal from said personal diagnostic device, said remote receivers linked to a network and said network further linked to a medical provider's computer system so that said at least some of said information about said diagnostic results is accessible by a medical provider at a remote location. 
     
     
       44. The device according to  claim 43  further comprising a receiver implemented within said personal diagnostic device operatively associated with said processor for accepting a control command signal from said medical provider's computer system. 
     
     
       45. The device according to  claim 43  further comprising a logic processing system operatively associated with said processor and implemented within said personal diagnostic device to control operational functions therein. 
     
     
       46. The device according to  claim 45  further comprising a drug-release reservoir having supply probes that penetrate into said user and said logic processing system includes logic and control functionality to release a pre-determined amount of liquid medication from a drug-release reservoir into said user through supply probes in response to a respective control command sent by said medical provider to said personal diagnostic device over said network. 
     
     
       47. The device according to  claim 46  wherein said drug-release reservoir is subdivided into a pre-selected number of sub-reservoirs each having a pre-determined amount of said liquid medication stored therein so that said amount of medication stored in each of said sub-reservoirs is releasable at different times for administration of a time-released application of said liquid medication over an extended period of time. 
     
     
       48. The device according to  claim 46  wherein said liquid medication includes a hormone. 
     
     
       49. The device according to  claim 48  wherein said hormone is insulin.